SAPPHIRE O/E ORAL EXAMINATION SYSTEM— 510(k) K073483

Name: FDA 510(k) clearance K073483
Creator: U.S. Food and Drug Administration
Published: 2008-04-03

Substantially Equivalent

Den-Mat Holdings, LLC

FDA 510(k) clearance K073483 for SAPPHIRE O/E ORAL EXAMINATION SYSTEM, Substantially Equivalent on 2008-04-03. Applicant: Den-Mat Holdings, LLC. Device class: 2.

Clearance details

Applicant: Den-Mat Holdings, LLC
Product code: Code NXV
Device class: Class 2
Regulation: 21 CFR 872.6350
Advisory panel: Dental
Date received: 2007-12-11
Decision date: 2008-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.